Clinical, Biochemical and Epigenetic Profile of Pediatric Behçet Disease: Similarities and Differences From Adult Patients and Looking for Potential Biomarkers.

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Behçet disease (BD) is a chronic multisystem inflammatory disorder with a relapsing-remitting course. Pediatric-onset BD is rare and characterized by marked clinical heterogeneity, frequent incomplete presentation at disease onset, and limited availability of pediatric-specific outcome measures and biomarkers. This prospective multicenter study aims to comprehensively characterize the clinical, biochemical, genetic, and epigenetic profiles of pediatric patients with Behçet disease and to compare them with adult BD patients and healthy pediatric controls. The study focuses on the identification of disease-associated cytokine patterns, circulating microRNA profiles, DNA methylation signatures, and genetic variants associated with monogenic autoinflammatory diseases presenting with a Behçet-like phenotype. By integrating clinical data with multi-omic analyses, this study seeks to identify biologically and clinically meaningful patient subgroups, improve disease stratification, and explore potential biomarkers of disease activity and remission in pediatric Behçet disease.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 70
Healthy Volunteers: f
View:

• BD diagnosis according to at least one of the three sets of classification criteria \[International Criteria for Behçet's Disease (ICBD), International Study Group (ISG) and Pediatric Behçet's disease criteria PEDBD)\];

• Age 6 months to 70 years old.

• Written informed consent from appropriate legal representative(s), and assent from patients who have not reached the age of consent.

Locations
Other Locations
Italy
Aou Meyer IRCSS
RECRUITING
Florence
United Kingdom
Alder Hey Children's Hospital,
NOT_YET_RECRUITING
Liverpool
Contact Information
Primary
Gabriele Simonini
gabriele.simonini@unifi.it
+390555662545
Time Frame
Start Date: 2026-01-12
Estimated Completion Date: 2036-01
Participants
Target number of participants: 90
Treatments
Other: Pediatric Behçet Disease Patients
Pediatric patients (\<18 years) with a diagnosis of Behçet disease. Blood samples collected during routine clinical visits will be analyzed for research purposes, including cytokine profiling, circulating microRNA analysis, DNA methylation profiling, and genetic sequencing. These analyses are not used for clinical decision-making.
Experimental: Adult Behçet Disease Patients
Adult patients (≥18 years) with a diagnosis of Behçet disease. Blood samples collected during routine clinical visits will be analyzed for research purposes, including cytokine profiling, circulating microRNA analysis, DNA methylation profiling, and genetic sequencing. These analyses are not used for clinical decision-making
Experimental: Healthy Pediatric Controls
Healthy pediatric subjects (\<18 years) undergoing routine blood testing for non-inflammatory conditions. Blood samples will be analyzed for research purposes, including circulating microRNA analysis and DNA methylation profiling, and used as reference controls for comparative analyses.
Related Therapeutic Areas
Sponsors
Leads: Meyer Children's Hospital IRCCS

This content was sourced from clinicaltrials.gov